Pregabalin Impurity 15 CAS 1083246-65-4

Purity >90%In StockPharmacopoeial Impurity Standards
CAS No.1083246-65-4
Molecular FormulaC16H32N2O3
Molecular Weight300.44 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Pregabalin Impurity 15 CAS 1083246-65-4 chemical structure

Description

The occurrence of Pregabalin Impurity 15 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Pregabalin Impurity 15 (CAS 1083246-65-4) is a certified pharmaceutical impurity reference standard with the molecular formula C16H32N2O3 and a molecular weight of 300.44 g/mol.

Based on its molecular formula C16H32N2O3, Pregabalin Impurity 15 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage; these features give the compound characteristic functional-group stretching vibrations in infrared spectroscopy. The molecular weight of 300.44 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.

As a certified reference material (CRM), Pregabalin Impurity 15 meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC16H32N2O3
Molecular Weight300.44 g/mol
Purity>90%
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening
Degree of Unsaturation (DBE)2.0
CAS Registry Year (est.)1989
Nitrogen Atoms2

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